From The Editor | February 15, 2019

New NonProfit Aims To Bring Data Transparency To Researchers

Ed Miseta

By Ed Miseta, Chief Editor, Clinical Leader

data sharing

Each day, researchers work on clinical trials that do not result in approved treatments for patients. Normally that data ends up being stored and never again sees the light of day. Unfortunately, patients and researchers invested a lot of time and effort into these studies, and other researchers working in the same therapeutic area could benefit greatly from the data.

This situation frustrated researchers at The Multi-Regional Clinical Trials (MRCT) Center of Brigham and Women’s Hospital and Harvard, a research and policy center promoting safe and ethical clinical trials. In 2012, The MRCT Center began work on a project to enhance access to clinical trial data by promoting data sharing and transparency. In 2013, THE MRCT Center joined forces with a diverse group of global stakeholders and embarked on a mission to define, design, and launch a solution that would enable global clinical trial data sharing.

In 2015, Vivli was launched as a centralized platform for those willing and able to share data. Vivli gained 501(c)(3) status, formed its executive leadership team, and held its first board meeting in 2017. That is the same year it began constructing the data sharing platform and research environment. Vivli 1.0 was launched to the public in July 2018. 

A Centralized Platform

Julie Wood
Vivli is a nonprofit and a neutral center for clinical data sharing. Vivli serves as a data broker and is agnostic to disease, country, sponsor, funder, and investigator. Vivli has established an independent data repository, analytics platform, and search engine through which entities can gain access to participant-level data and metadata from trials. Those trials could be conducted by academia, pharma companies, foundations, and nonprofit entities. The data can be identified, hosted, shared, and analyzed.

“For the industry to have true data transparency, patient-level data must be easily accessible for aggregation and analysis among multiple sources,” says Julie Wood, director of strategy and operations at Vivli. “That will enable the widest range of use of the data for secondary research purposes. Current gaps in data hosting, aggregation, and meta-analysis make it difficult to find what trial data is available for sharing. We offer a solution to current challenges by harmonizing policies and processes for data submission, data requests, data access, and the sharing of academic credit.”

As a nonprofit, Vivli serves a crucial convening function for the biomedical industry, academia, nonprofit funders and foundations, government, and patients/patient advocates. The platform offers a secure and user-friendly data sharing and computing environment. Additionally, it offers users the ability to discover and combine large clinical trial datasets from disparate sources into a single platform with access to statistical tools for analysis.

Gathering The Data

Data is contributed to the platform by the organization or principal investigator conducting the trial. This would typically be a pharma company or academic institution. Users of the data would be the entities requesting the data sets for secondary analysis. This could again be a pharma company, academic institution, or another qualified researcher. Data users are researchers who specifically request those data sets for secondary analysis. The platform is open and available to all users for searching and requesting data. According to Wood, anyone can put in a request. But for the request to be granted, the research team needs to have the skills necessary to conduct the analysis. For example, a research team would need to have a member who previously conducted this type of analysis or has a degree in biostatistics or a similar field.

Currently Vivli’s mission is to share data from completed trials to advance science and research. It does not, however, have the ability to share trial data with the patients participating in the study. Still, that is not expected to discourage trial participants from agreeing to share their data.

Additionally, Wood points to published studies showing the willingness of patients to share their data to help further research into their disease. One of those studies surveyed 771 current and recent trial participants. Less than eight percent of respondents felt potential negative consequences of data sharing outweighed the benefits. The survey found 93 percent of trial participants were very likely or somewhat likely to share their own data with university scientists. That figure dropped to 82 percent when the data would be shared with scientists at for-profit companies. When asked about their greatest concerns over data sharing, participants cited data sharing making patients less likely to participate in trials, the data being used for marketing purposes, and the potential for the data to be stolen.

Funding The Platform  

Although Vivli is a nonprofit, it still requires funding to provide its data sharing platform. Funders of the effort include PhRMA, The Helmsley Charitable Trust, the Doris Duke Charitable Foundation, the Lyda Hill Foundation, and the Laura and John Arnold Foundation.

Vivli also receives income via data contributors and data requestors who contribute to the administrative costs of running the platform. Data requestors are charged a nominal cost for use of the secure research environment after a specified period of time, which is typically after 12 months of use. The charge is $12 per day or $25 per day, depending on whether members opt for the standard or premium membership. Wood notes access to the data is free. Members simply pay to access the research environment. The 16 current members include pharma companies such as Pfizer, GSK, and AbbVie. Duke University, Johns Hopkins University, and Harvard University are also on the membership list.

Keeping patient data safe was a primary concern for the Vivli team. “The platform was designed and built to ensure the security of the anonymized clinical trial participant data that it hosts,” says Wood. “The Vivli platform is built entirely as an application within the Microsoft Azure Cloud, thus taking advantage of the numerous security features developed by Microsoft’s system and processes. Vivli selected Microsoft Azure as it possesses some of the most robust compliance offerings of any cloud service provider. Additionally, the Vivli platform itself has achieved SOC 2, Type 1 compliance by a third party and has successfully passed a full-penetration test.

Wood believes industry sponsors and academic institutions are looking for comprehensive trial transparency solutions to manage the disclosure of data on trial registries and websites. Many have also expressed interest in data-sharing initiatives that provide access to richer clinical trial data such as anonymized individual patient data (IPD). Data providers, including industry trial sponsors, can work directly with Vivli to host their data, and researchers can request data access directly from Vivli. The organization is also partnering with technology provider TrialScope to provide an end-to-end solution to facilitate disclosure and data sharing.